# FDA 483 - GlaxoSmithKline Biologicals SA - February 27, 2026

Source: https://www.keypedia.com/records/483/glaxosmithkline-biologicals-sa/5f71a11f-34f5-4c18-b116-e55851281d28

> FDA 483 for GlaxoSmithKline Biologicals SA on February 27, 2026. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: GlaxoSmithKline Biologicals SA
- Inspection Date: 2026-02-27
- Product Type: biologics
- Office Name: Division of Blood Components and Devices
- Summary: GlaxoSmithKline Biologicals SA in Rixensart, Belgium, a licensed biological drug manufacturer, was cited for significant deficiencies in its environmental monitoring program. Observations included a failure to verify the effectiveness of corrective actions following environmental monitoring action limit excursions and a lack of procedures for assessing the impact on drug substance batches. Additionally, the firm failed to routinely monitor temperature and humidity in aseptic processing areas for Hepatitis B vaccine production, contrary to its own written procedures and without scientific justification.

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## Related Officers

- [Investigator](https://www.keypedia.com/people/thai-d-truong/7395c128-0adb-44a1-8831-64673c98e93d)
- [Shafiq Ahadi](https://www.keypedia.com/people/shafiq-ahadi/593bbf28-02e6-47bb-86c3-65cbd4ec520d)

Company: https://www.keypedia.com/companies/glaxosmithkline-biologicals-sa/ef569005-49c7-4bf9-b3f1-7814705bec8e

Office: https://www.keypedia.com/offices/division-of-blood-components-and-devices/02cc5ccf-d21e-445f-91e7-474736bc8917